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Biotech / Medical : Trimeris (TRMS)
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To: Pluvia who wrote (85)10/1/2000 2:26:58 PM
From: Cacaito  Read Replies (2) of 108
 
Pluvia, interesting comments, but I read the links and I do not find reference to the use of the "genotype based drug selection" as been SPECIFICALLY used during Trimeris PII study.

Of course that drug changes will happen in this type of study cause it is not ethical not to do so, a larger study will be needed to account for the difference (or the lack of it)kind of the problem that Amylin went through.

Please, provide if you find the specific reference of the genotyping used in Trimeris T20 pII study it will be helpful to evaluate this problem.

Trimeris does used genotyping to design the T20 target, specifically some of the non-mutant areas of the viral gp41 that they aim to block. This is not the same as the Durant study.

gp120 is more mutant prone than gp41, and gp41 is the one that actually binds to the cell it will attack.

The cocktail drugs act via reverse transcriptase inhibition or protease inhibition, NOT at the fusion level. Even if one will select drugs by genotype it will be at different molecular level.

In favor of your view is that the effect on a trial like T20 pII could be "confounded", selection will improve the patient base on the selected coktail (If it was done with that purpose, and no evidence of that I have seen in the links provided) and not due to T20.

In favor of your view is that it could happen even inadvertenly just by changing the patients drugs.

Trimeris pII design (and the upcoming pIII)must have this into account during analysis (actually predetermined before study start). If they did not then attributing the results to T20 is a tentative "good trend" at best, at worst just plain lack of efficacy.

I have no position at the time. Price is too high even with the if one leave "confounding" issues aside.
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